US clears 4 new generics by Indian cos

Indian drugmakers get approvals to market drugs with a market size of Rs 15,000 cr, reports Suprotip Ghosh.

Indian drugmakers, two of which have Mumbai connections, got approvals to market four generic drugs with a cumulative market size of three and a-quarter billion dollars (Rs 15,000 crore). The four US Food and Drug Administration (USFDA) approvals include a major award for Mumbai-based Lupin Limited for Pfizer’s Zoloft.

Zoloft is the number one blockbuster drug from the Pfizer stable. It is used for disorders such as depression and anxiety. The drug is medically known as Sertraline Hydrochloride. Lupin expects final FDA approval after the market exclusivity for Zoloft expires in February. Industry estimates indicate that blockbuster drugs worth $ 10 billion (Rs 44,000 crore) would go off patent by 2010.

Ranbaxy and Mumbai-based IPCA Laboratories’ joint venture ‘Atenolol’ tablets too has got the nod from the USFDA. The drug is second in line to get an approval from the joint venture after Furosemide, or Lasix, a Ranbaxy spokesperson said. The alliance was formed in September 2006.

According to norms of the contract, the $ 1 billion Ranbaxy would market and support challenges for IPCA Labs for drugs in the US. IPCA Labs makes formulations, and Ranbaxy would use these to market their generic drugs in the US market through its US subsidiary Ranbaxy Pharmaceuticals Inc.

With the recent approval, the tally that Ranbaxy has garnered stands at 112 in the US in the first three quarters of the year 2006.

Aurobindo Phama (APL), the Hyderabad-based drug major, has received USFDA approvals to market multiple dosages of Bisoprolol and anti-biotic Amoxicillin in the US. This takes the number APL’s approvals to 35.

Bisoprolol is used in the treatment of cardiovascular diseases, in 5 mg, 10 mg dosages and Amoxicillin oral suspension in 200 mg5ml and 400mg5ml to treat respiratory infections.

Bisoprolol is a generic version of a Pharms Barr drug used for treating hypertension, coronary heart diseases and arrhythmias during the treatment of cardiovascular diseases according to a company source.